Download Embrace Life

Embrace Life
without Enlarged Prostate
Because results matter.
About Enlarged Prostate or BPH
Benign prostatic hyperplasia (BPH) is the medical term
for an enlarged prostate and Cooled ThermoTherapy,™
a safe and durable outpatient procedure performed in
your urologist’s office, is a leading minimally invasive
procedure that is used to treat BPH.
“After 3 years of paying for drug therapy and letting BPH run my life I decided to take
action in the form of a Cooled ThermoTherapy procedure. Cooled ThermoTherapy gave me my life back! I can now go out to dinner and
not have to plan my meal around trips to the
bathroom. The advice I have to my peers is not to wait. Seek out a urologist and find out if
Cooled ThermoTherapy is right for you.”
Tom Hiland, Lakewood, CO
Table of Contents
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About Enlarged Prostate or BPH
Management & Treatment Options
Cooled ThermoTherapy ™ Questions and Answers
What to Expect With Cooled ThermoTherapy ™
How to Assess Your Symptoms
Glossary
BPH is one of the most common medical conditions
among men over 50. It is non-cancerous and occurs
naturally during the aging process as the number of
prostate cells increases. The progression of BPH causes the
prostate gland to become larger and compress the urethra
causing frequent and sometimes painful or difficult
urination. Interference with sexual activity may also occur.
Severe BPH can cause urinary retention, requiring an
immediate trip to the emergency room. To assess your
symptoms turn to page 11 of this brochure.
How do you know if you have BPH? The symptoms include a frequent
or urgent need to urinate, difficulty starting and/or sustaining urination
or a feeling of being unable to completely empty your bladder.
Millions of men take medication for BPH, which is
often prescribed after they discuss their symptoms with a
physician. However, drug therapy means taking medication
every day for life. Many men find this difficult and
expensive. Some experience side effects; for others, the
medications’ effectiveness decreases over time and BPH
symptoms return.
For all these reasons, urologists often recommend a
minimally invasive procedure as an alternative in BPH
treatment. Cooled ThermoTherapy provides effective
and lasting results, allowing men to stop taking BPH
medication and avoid surgery.
1
Management & Treatment Options
There are three main approaches to the treatment of
BPH: prescription drugs, minimally invasive procedures
and surgery.
Drug Therapy
Doctors commonly recommend drug therapy as the
initial treatment for BPH. While medicines may relieve
your BPH symptoms, at least initially, none of these
drugs stops the progression of the disease.
If you have BPH, you may be taking one or a combination
of these medications:
Side Effects. For some men, BPH medications cause
unwanted side effects, such as dizziness, low blood pressure,
loss of sex drive and erectile dysfunction.
Convenience. For many mature men, the hassle of having
to take an additional pill when they may be on a variety
of medications is burdensome.
Cost. For many men and their families, the cost of BPH
medication is an expensive and inconvenient burden.
BPH patients can expect to spend thousands of dollars
on these medications over a period of five years.
•Avodart® (dutasteride) and Proscar® (finasteride)5 Alpha Reductase Inhibitor drugs interfere with
the production of a hormone involved with BPH,
shrink the prostate and improve symptoms.
• Flomax® (tamsulosin), Cardura® (doxazosin),
Hytrin® (terazosin), and Uroxatral® (alfuzosin)
are Alpha Blocker drugs. They can help to
relax the smooth muscle of the prostate and
bladder neck, potentially improving urine flow.
Long-Term Effectiveness. While medications provide
initial relief from BPH symptoms, some men find
that the drugs’ effectiveness decreases over time and
their symptoms return. When compared to Cooled
ThermoTherapy at one year, various drug therapies
show significantly less improvement in BPH symptoms.1
1 Djavan, Heat versus Drugs in the Treatment of BPH, BJU International, 91, 131-137: 2003.
2
3
Office-Based Procedures
Surgery
Men who seek long-term relief of their BPH symptoms
often choose a minimally invasive office-based procedure
over surgery. If you don’t want to take medication forever,
or your enlarged prostate medication stops working,
you should consult with your doctor to determine if a
minimally invasive option is right for you.
Prior to 1993, surgery was the only therapeutic solution
available for men with BPH. Today, it is offered to
patients who do not respond to other treatments or
who cannot tolerate BPH medication. Surgery provides
the most improvement in symptoms but has a higher
incidence of complications. If you have prostate surgery,
you will need general anesthesia and will have to stay in
the hospital, probably for 1 to 3 days.
These procedures utilize targeted heat energy and catheter
technologies to destroy enlarged prostate tissue and
relieve pressure on the urethra. Office-based procedures
typically are performed with oral medications in a
urologist’s office.
Cooled ThermoTherapy is a leading minimally invasive
procedure for BPH. Urologists choose it for its proven
safety and long-lasting effectiveness, which have been
documented in numerous clinical articles and presentations.
During the procedure, unique cooling mechanisms protect
healthy tissue and enable more BPH tissue to be removed
than other office-based procedures.
When compared to various drug therapies one year
after treatment is started, Cooled ThermoTherapy shows
significantly more improvement in BPH symptoms.
Cooled ThermoTherapy studies have shown significant
and lasting improvement in BPH symptoms for up to five
years following treatment. For precautions associated with
Cooled ThermoTherapy, see the brief statement on the
back of this brochure.
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Transurethral Resection of the Prostate. TURP is a
common surgical BPH procedure. The inner portion of
the prostate is surgically removed. There is some risk of
serious complications. Approximately 10% of TURP
patients need another procedure within 5 years. Postsurgical problems can include erectile dysfunction,
ejaculation problems and urinary incontinence.
Laser Surgery. A variety of laser procedures have been
introduced over the past few years. Short-term improvement
in symptoms are similar to TURP, but with fewer
complications. However, extensive clinical data confirming
the long-term viability of laser surgery is not yet available.
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Cooled ThermoTherapy Question and Answers
Below are answers to some of the most frequent questions
about the procedure.
Q: W
hy should I have a minimally
invasive procedure?
If you are looking for long-term relief of your BPH
symptoms, with few side effects, you may choose a minimally
invasive procedure over surgery. These procedures are typically
performed in a doctor’s office or hospital outpatient setting
and you won’t have to stay overnight in the hospital.
If you don’t want to take medication forever, or your
enlarged prostate medication stops working, you and
your doctor should determine if a minimally invasive
option is right for you.
Q: What is Cooled ThermoTherapy?
Cooled ThermoTherapy delivers precisely targeted energy to
destroy enlarged prostate tissue. Unique cooling mechanisms
protect the healthy surrounding urethral tissue. Cooling the
urethra reduces the need for anesthesia and provides a more
rapid recovery. It allows concentrated energy to be used to
destroy enlarged prostate tissue and provides long-lasting
reduction in the symptoms associated with BPH.
•It does not require hospitalization, general anesthesia
or long recovery times.
•The unique cooling mechanism is the key to treating
symptoms of BPH safely, effectively and comfortably.
•Cooled ThermoTherapy has been approved by
the FDA since 1996 and has been endorsed in
BPH treatment guidelines issued by the American
Urological Association (AUA), European Association
of Urology and the World Health Organization.
Q: How does Cooled ThermoTherapy work?
Cooled ThermoTherapy procedures are typically performed
with oral medication. The treatment time is typically
30 minutes. Your urologist will place a catheter in your
urethra and a small balloon near the tip of the catheter
will inflate to anchor the catheter in place. To ensure safety,
temperatures are monitored in both the urethra and rectum
during the procedure.
Q: Why should I choose Cooled ThermoTherapy?
•More than 200,000 1 men have undergone
this treatment.
•The procedure’s safety and effectiveness have been
documented in numerous peer-reviewed clinical
articles and presentations.
•Cooled ThermoTherapy is cost-effective and has
few side effects.
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1 Data on file at Urologix, Inc.
The Cooled ThermoTherapy catheter delivers precisely targeted heat
energy to destroy enlarged prostate tissue. Cooled water circulates
through the catheter during the procedure allowing delivery of the
optimal amount of heat while protecting healthy tissue.
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What to Expect With Cooled ThermoTherapyTM
Q: Is the procedure painful?
What to expect before the procedure:
To maximize patient comfort, your urologist may use
oral medications during the procedure. Most patients
feel some heat during the procedure and some patients
experience urgency associated with the need to urinate.
Individual responses vary.
•You’ll need a physical examination from a urologist
trained in performing the procedure. Your urologist
will explain the procedure in detail and answer
your questions.
•Your urologist will provide specific pre-procedure
instructions, such as reducing fluid intake or
modifying your diet the day of the procedure.
Q: What kind of results can I expect after my
Cooled ThermoTherapy procedure?
Cooled ThermoTherapy can give you and your loved
ones the kind of durable results you are looking for.
Studies have shown significant and lasting improvement
in several different measures of BPH symptoms up to five
years following treatment. These measures include the
AUA Symptom Score and quality of life scores. As with
any medical procedure, individual results will vary. Please
consult your urologist for more information.
Q: Is Cooled ThermoTherapy expensive?
Cooled ThermoTherapy is a very cost-effective procedure
when compared to drugs and surgery. Most symptomrelieving medications must be taken daily and may cost
each patient thousands of dollars annually. Surgery, while
effective, is significantly more expensive than Cooled
ThermoTherapy.
Q: Is Cooled ThermoTherapy covered by insurance?
Medicare and many commercial insurance plans provide
coverage. If your insurance plan needs more information
before making a coverage decision, you can ask your
doctor’s office for assistance.
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What to expect during the procedure:
•Cooled ThermoTherapy is performed in your
urologist’s office. You will be awake during the
procedure, which usually takes 30 minutes. You
should allow 2 hours for the entire office visit.
•You will be on an exam table in a comfortable
position. You may be able to watch television,
read a book or listen to music during the
procedure. You may be given medication
to help you relax.
•Once the procedure begins you may experience
some slight discomfort and sensations in your
bladder, bowels or abdomen. The medical staff
will make you as comfortable as possible.
What to expect immediately after the procedure:
•Arrange in advance for someone to drive you
home after the procedure.
•Because the tissue surrounding the urethra may
be irritated after the procedure, you may go
home with a urinary catheter.
•For several weeks after the procedure, you may
experience soreness in the lower abdomen or
frequent urination, but these will dissipate as
you heal.
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How to Assess Your Symptoms
less than half the time
about half the time
more than half the time
almost always
How often have you had to push
or strain to begin urination?
0
1
2
3
4
5
How often have you had the
sensation of not emptying your
bladder completely after you
finished urinating?
0
1
2
3
4
5
How often have you had to
urinate again less than two hours
after you finished urinating?
0
1
2
3
4
5
How often have you found
you stopped and started again
several times when you urinate?
0
1
2
3
4
5
How often do you find it
difficult to stop urination?
0
1
2
3
4
5
How often have you had a
weak urination stream?
0
1
2
3
4
5
How many times did you most
typically get up to urinate from
the time you went to bed at
night until the time you got
up in the morning?
0
1
2
3
4
5
score
less than one time in five
•You may not notice any change in your
BPH symptoms immediately after Cooled
ThermoTherapy. However, your body is
actively working to heal itself.
•In the weeks after the procedure, your body
will reabsorb the tissue treated with Cooled
ThermoTherapy and your prostate will shrink,
decreasing pressure on your urethra over a
period of up to several months.
•Some men start to see an improvement in
symptoms as early as 4 weeks, but most men
have significant improvement in 6-12 weeks.
Individual results vary.
To check your symptoms of enlarged prostate, complete
the following questions based on your experience over
the past month or two. (Circle your answers)
not at all
Healing and results:
Total:
The higher your total score, the more likely you are suffering from an
enlarged prostate. No matter what the total of the survey, if you are
unhappy with how your urination problems are affecting your life, see
a urologist for a complete check-up.
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Glossary
The first references to the terms defined below can be found in bold
type in each section of this brochure.
5 alpha reductase inhibitor drugs – These drugs, often prescribed to
men with BPH symptoms, interfere with the production of a hormone
involved with BPH, shrink the prostate and improve symptoms.
AUA Symptom Score – The most widely used gauge of the lower
urinary tract symptoms associated with the constriction of the urethra
caused by an enlarging prostate. Symptoms measured include urgency
and frequency of urination, problems with urination, and nocturia
(getting up at night to urinate).
Alpha blocker drugs – These drugs can help to relax the smooth
muscle of the prostate and bladder neck, potentially improving
urine flow and reducing blockage of the bladder.
BPH (benign prostatic hyperplasia) – The medical term for an
enlarged prostate. It is one of the most common medical conditions
among mature men. BPH is not cancer, but a natural part of the aging
process that occurs when the number of prostate cells increases. The
progression of BPH causes the prostate gland to compress the urethra.
Cooled ThermoTherapy™ – This is the leading office-based treatment
for BPH. Urologists have used it to treat more than 200,000 men.
A unique cooling mechanism is the key to Cooled ThermoTherapy’s
safety, effectiveness and long-lasting results.
Enlarged prostate – Also known as benign prostatic hyperplasia
(BPH).
Erectile dysfunction – The inability to have or maintain an erection
of the penis.
Laser surgery – A variety of laser procedures have been introduced
over the past few years as a replacement for traditional TURP.
Minimally invasive procedures – These procedures utilize targeted
heat energy and catheter technologies to destroy enlarged prostate
tissue and relieve pressure on the urethra. They are performed with
local anesthesia or oral medications in a urologist’s office or hospital
outpatient setting.
Prostate – A gland that surrounds the neck of the bladder and the
urethra in the male. It is partly muscular and partly glandular and
consists of a median lobe and two lateral lobes. The gland secretes a
fluid that forms part of the seminal fluid.
TURP – Transurethral resection of the prostate is the most common
surgical BPH procedure. The inner portion of the prostate is surgically
removed.
CONTRAINDICATIONS
• P
atients with a prostatic urethra <2.5 cm in length as measured
from the bladder neck to the verumontanum
• P
atients with urinary sphincter or any implant (metallic
or non-metallic) which is within 1.5 inches (38 mm) of the
prostatic urethra
• Patients with urethral stricture (unable to pass 22 F urethroscope)
• P
atient with peripheral arterial disease with intermittent
claudication or Leriches Syndrome (i.e. claudication of the
buttocks or perineum)
• Patients who have undergone pelvic radiation therapy
• P
atients with implanted active devices, including pacemakers or
defribrillators within 2.6 inches (6.5 cm) of the prostatic urethra
WARNINGS AND PRECAUTIONS
• This procedure has inherent associated risks of complications.
• P
ost-treatment catheterization is needed in most cases
after treatment.
ADVERSE EVENTS AND COMPLICATIONS
• M
en who may wish to have further offspring should note the loss
of ejaculation and/or decreased volume of ejaculate in some cases.
• O
ther associated risks include: temporary acute urinary retention,
temporary incontinence, clots in urine, bladder spasms and
trabeculation, rectal fistula, minimal bleeding, pain during
urination and intercourse, pain or irritation in groin or pelvis,
hemospermia, prostatic urethral damage, rectal irritation,
interrupted flow, frequency, hesitation, urgency, post-void
dribbling, weak stream, urinary tract infection, blood pressure
changes during treatment and hospitalization in general related
to the treatment.
• There is a minimal risk of urethral stricture post procedure.
• P
atients may be prescribed anti-inflammatory and antibiotic
medications following the procedure.
• P
atients may require use of analgesics or sedatives during
the procedure.
CAUTION
Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician trained and/or experienced in the use of this device as
outlined in the required training program.
Urethra – A canal for the discharge of urine extending from the
bladder to the outside of the body.
Urinary incontinence – The involuntary discharge of urine.
Urinary retention – Inability to empty the bladder.
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First Mi. Last, M.D.
Practice Name
Street Address, Suite Number
City Name, ST Zip Code
Phone Number
www.webaddress.com
For more information please visit our website,
www.urologix.com, and/or call our patient hotline
at 1-888-4-BPH-HLP.
Urologix, Inc.
14405 Twenty-First Avenue North
Minneapolis, MN 55447-4685
Telephone: 763.475.1400
Toll free: 800.475.1403
Fax: 763.475.1443
www.urologix.com
©2007 Urologix, Inc.
All rights reserved. Printed in USA.
MC1195 Rev C 03/07